2015/06/04

Clinical Chemistry A93A01303CEN

A11A01640

90 mL
ABX Pentra
Triglycerides CP

■ Pentra C400

Diagnostic reagent for quantitative in vitro determination of Triglycerides in

serum or plasma by colorimetry.

Application Release Glycerokinase

Glycerol + ATP ————————▶ Glycerol-3-phosphate + ADP

Glycerol-3-phosphate Oxidase
Serum, plasma: Trigly Glycerol-3-Phosphate + O2 ——————————————▶ H2O2 + DHAP

1.xx Peroxidase
2H2O2 + 4-AAP + p-Chlorophenol ——————▶ Quinoneimine + 4H2O

Intended Use (DHAP = Dihydroxyacetone phosphate, 4-AAP = 4-

aminoantipyrine)
ABX Pentra Triglycerides CP reagent is intended for the
quantitative in vitro diagnostic determination of
triglycerides in human serum and plasma based on an Reagents
enzymatic colorimetric assay. Measurements obtained by
this device are used in the diagnosis and treatment of ABX Pentra Triglycerides CP is ready-to-use.
patients with diabetes mellitus, nephrosis, liver
obstruction, other diseases involving lipid metabolism, or Reagent:
various endocrine disorders. PIPES free acid 50 mmol/L
Sodium hydroxide 3.36 g/L
Clinical Interest (1, 2) Triton X-100 1 mL/L
Magnesium salt 14.8 mmol/L
Triglycerides constitute 95% of fat stocked in tissues and
their main role is to provide energy to cells. They are p-chlorophenol 2.7 mmol/L
synthetised on one hand in the intestine from fat brought ATP 3.15 mmol/L
by food and on the other hand in liver from ingested Sodium azide 7.99 mmol/L
saccharides, and are then transported in the blood by
Potassium ferrocyanide 10 µmol/L
chylomycrons and very low density lipoproteins (VLDL).
High levels of triglycerides are associated with important 4-aminoantipyrine 0.31 mmol/L
risks of atherosclerosis. They may be caused by diseases Lipoprotein lipase ≥ 2000 U/L
such as different lipid metabolism troubles Glycerokinase ≥ 500 U/L
(hyperlipoproteinemia, deficit in lipase activity, deficit in
Glycerol phosphate Oxidase ≥ 4000 U/L
apolipoprotein CII), but also by diabetes, renal or
endocrinal troubles. Peroxidase ≥ 500 U/L

ABX Pentra Triglycerides CP should be used according

Method (3) to this reagent notice. The manufacturer cannot
QUAL-QA-TEMP-0846 Rev.9

guarantee its performance if used otherwise.

Enzymatic determination of triglycerides according to the
following reactions:
Lipoprotein lipase
Triglycerides + H2O ————————▶ Glycerol + fatty acids

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 Clinical Chemistry

ABX Pentra
Triglycerides CP

Handling Anticoagulants other than those listed have not been

tested by HORIBA Medical and are therefore not
recommended for use with this assay.
1. Remove the cap of the cassette.
2. If present, remove foam by using a plastic pipette. These specimens should be drawn from the patient after
12 - 14 h fast.
3. Place the cassette into the refrigerated Pentra C400
reagent compartment. Stability (4):
No significant change of triglycerides concentration after
storage for 4 days at 4°C.
Calibrator

For calibration, use: Reference Range (2)

ABX Pentra Multical, Ref. A11A01652 (not included)
10 x 3 mL (lyophilisate) Each laboratory should establish its own reference
ranges. The values given here are used as guidelines only.

Control In a study conducted within the NCEP (National

Cholesterol Education Program, launched by the US
For internal quality control, use: Ministry of Health), the triglycerides values in serum have
ABX Pentra N Control, Ref. A11A01653 (not included) been classified according to the risk of developing
10 x 5 mL (lyophilisate) cardiovascular diseases:
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 mL (lyophilisate) Normal: < 150 mg/dL
Low risk: 150 - 200 mg/dL
Each control should be assayed daily and/or after a High: 200 - 500 mg/dL
calibration. Extremely high: > 500 mg/dL
The frequency of controls and the confidence intervals
should correspond to laboratory guidelines and country-
specific directives. You should follow federal, state and Storage and Stability
local guidelines for testing quality control materials. The
results must be within the range of the defined confidence Reagents, in unopened cassettes, are stable up to the
limits. Each laboratory should establish a procedure to expiry date on the label if stored between 2-8°C.
follow if the results exceed these confidence limits. Stability after opening: refer to the paragraph
"Performance on Pentra C400".

Materials Required but not Provided Note: the reagents' colour may change to brown in the
course of time, but this does not affect the reagent
performance.
■ Automated clinical chemistry analyzer: Pentra C400
■ Calibrator: ABX Pentra Multical, Ref. A11A01652
■ Controls: Waste Management
ABX Pentra N Control, Ref. A11A01653, and
ABX Pentra P Control, Ref. A11A01654 Please refer to local legal requirements.
■ Cleaning solution:
ABX Pentra Clean-Chem CP, Ref. A11A01755, 30 mL ■ Please refer to local legal requirements.
or ■ This reagent contains less than 0.1% of sodium azide
ABX Pentra Clean-Chem 99 CP, Ref. A11A01789, 4 x as a preservative. Sodium azide may react with lead
99 mL and copper to form explosive metal azides.
■ Standard laboratory equipment.

Specimen (4)

■ Serum.
■ Plasma in lithium heparin.

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 Clinical Chemistry

ABX Pentra
Triglycerides CP

General Precautions a Accuracy and Precision:

■ Repeatability (within-run precision)

■ This reagent is for professional in vitro diagnostic use
only. 3 specimens of low, medium and high concentration and
■ For prescription use only. 2 controls are tested 20 times according to the
■ This reagent is classified as non-hazardous in recommendations found in the Valtec protocol (5).
compliance with regulation (EC) N°.1272/2008.
■ Observe the standard laboratory precautions for use.
Mean value CV %
■ The reagent cassettes are disposable and should be
disposed of in accordance with the local legal mmol/L mg/dL
requirements. Control 1.44 126 2.52
■ Please refer to the MSDS associated with the reagent. specimen 1
■ Do not use the product if there is visible evidence of Control 2.44 214 0.82
biological, chemical or physical deterioration. specimen 2
■ It is the user's responsibility to verify that this Specimen 1 0.68 60 2.83
document is applicable to the reagent used.
Specimen 2 1.24 108 1.84
Specimen 3 2.65 232 1.00
Performance on Pentra C400
■ Reproducibility (total precision)
The performance data listed below are representative of
performance on HORIBA Medical Systems. A variance analysis (ANOVAR) is carried out for 6 days out
of 2 specimens (medium and high levels) and 2 controls
Number of Tests: 295 tests (n=36).
If the number of tests requested is low and the
Pentra C400 user intends to utilise the cassette to the Mean value CV %
maximum on board stability, it is the recommendation of
mmol/L mg/dL
HORIBA Medical, to utilise the consumable part XEC083
(Kit membrane) to achieve the number of tests stated in Control 1.47 128 1.91
specimen 1
this notice.
Control 2.47 216 1.70
On Board Reagent Stability: specimen 2
Specimen 1 1.51 132 1.57
Once opened, the reagent cassette placed in the
refrigerated Pentra C400 compartment is stable for 48 Specimen 2 2.78 243 1.37
days.
Measuring Range:
Sample Volume: 3 µL/test
The assay confirmed a measuring range from 0.08 to
Detection Limit: 16.39 mmol/L (7 to 1434.1 mg/dL), with an automatic
post-dilution up to 67.20 mmol/L (5880 mg/dL).
The detection limit is determined according to the Valtec The reagent linearity has been assessed up to
protocol (5) and equals 0.08 mmol/L (7 mg/dL). 16.8 mmol/L (1470.0 mg/dL) according to the
recommendations found in the CLSI (NCCLS), EP6-A
protocol (6).

Correlation:
135 patient samples (serum) are correlated with a
commercial reagent taken as reference according to the
recommendations found in the CLSI (NCCLS), EP9-A2
protocol (7). Values ranged from 0.04 to 16.39 mmol/L
(3.1 to 1434.1 mg/dL).

aModification: general precautions modification.

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 Clinical Chemistry

ABX Pentra
Triglycerides CP

The equation for the allometric line obtained using 3. Fossati P, Prencipe L, Serum triglycerides
Passing-Bablock regression procedure (8) is: determined colorimetrically with an enzyme that
Y = 0.99 X + 0.00 (mmol/L) produces hydrogen peroxide. Clin. Chem. (1982) 28:
Y = 0.99 X + 0.20 (mg/dL) 2077.
with a correlation coefficient r2 = 0.9994. 4. Thomas L. Clinical Laboratory Diagnostics. 1st Ed.
Frankfurt: TH-Books Verlagsgesellschaft, (1998):
169-170.
Interferencesb:
5. Vassault A, Grafmeyer D, Naudin C et al. Protocole
Haemoglobin: No significant influence is observed de validation de techniques (document B). Ann. Biol.
up to 290 µmol/L (500 mg/dL). Clin. (1986) 44: 686-745.
Total Bilirubin: No significant influence is observed 6. Evaluation of the Linearity of Quantitative Analytical
up to 385 µmol/L (22.5 mg/dL). Methods. Approved Guideline, CLSI (NCCLS)
Direct Bilirubin: No significant influence is observed document EP6-A (2003) 23 (16).
up to 385 µmol/L (22.5 mg/dL). 7. Method Comparison and Bias Estimation Using
N-Acetylcysteine Patients treated with N- Patient Samples. Approved Guideline, 2nd ed., CLSI
(NAC): Acetylcysteine (NAC) for (NCCLS) document EP9-A2 (2002) 22 (19).
Paracetamol overdose may generate 8. Passing H, Bablock W. A new biometrical procedure
a false low result. for testing the equality of measurements from two
Other limitations are given by Young as a list of drugs and different analytical methods. J. Clin. Chem. Clin.
preanalytical variables known to affect this methodology Biochem. (1983) 21: 709-20.
(9, 10). 9. Young DS. Effects of Drugs on Clinical Laboratory
Tests. 4th Edition, Washington, DC, AACC Press
Calibration Stability: (1997) 3: 143-163.
10. Young DS. Effects of Preanalytical Variables on
The reagent is calibrated on Day 0. The calibration Clinical Laboratory Tests. 2nd Edition, Washington,
stability is checked by testing 2 control specimens. DC, AACC Press (1997) 3: 120-132.
The calibration stability is 14 days.
Note: A recalibration is recommended when reagent lots
change, and when quality control results fall outside the
range established.

Application release:

1.xx

Conversion factor:

mmol/L x 0.875 = g/L

mmol/L x 87.5 = mg/dL

Reference
1. Naito HK, Coronary Artery Disease and Disorders of
Lipid Metabolism. Clinical Chemistry: Theory,
Analysis, Correlation, 4ème Ed., Kaplan LA, Pesce AJ,
Kazmierczak SC. (Mosby, Inc. eds. St Louis USA),
(2003): 603.
2. Expert Panel on Detection, Evaluation and Treatment
of High Blood Cholesterol in Adults (Adult Treatment
Panel III), Executive Summary of the Third Report of
the National Cholesterol Education Program (NCEP).
JAMA, (2001) 285: 2486.

bModification: modification of interferences.

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